Method and apparatus for repairing vascular abnormalities and/or other body lumen abnormalities using an endoluminal approach and a flowable forming material

ABSTRACT

A method for repairing an abnormality in the wall of a body lumen, the method comprising:
         isolating the abnormality in the wall of the body lumen from flow in the body lumen;   positioning flowable forming material adjacent to the abnormality in the wall of the body lumen; and   transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen.       

     Apparatus for repairing an abnormality in the wall of a body lumen, the apparatus comprising:
         a supply of flowable forming material;   zone isolation apparatus for isolating the abnormality in the wall of the body lumen from flow in the body lumen; and   positioning apparatus for positioning the flowable forming material adjacent to the abnormality in the wall of the body lumen so as to repair the abnormality in the wall of the body lumen.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application claims benefit of:

(i) pending prior U.S. Provisional Patent Application Ser. No.61/189,670, filed Aug. 21, 2008 by Howard Riina et al. for METHOD ANDAPPARATUS FOR ACCESSING THE SIDE WALL OF A VASCULAR STRUCTURE OR OTHERBODY LUMEN, ORGAN OR TUBULAR STRUCTURE WHILE SIMULTANEOUSLY PROVIDINGZONE ISOLATION AND BYPASS CAPABILITY (Attorney's Docket No. CORN-0615PROV); and

(ii) pending prior U.S. Provisional Patent Application Ser. No.61/131,584, filed Jun. 10, 2008 by Howard Riina et al. for INJECTABLEMOLD (Attorney's Docket No. CORN-13 PROV).

The two above-identified patent applications are hereby incorporatedherein by reference.

FIELD OF THE INVENTION

This invention relates to medical procedures and apparatus in general,and more particularly to medical procedures and apparatus for accessingthe wall of a vascular structure or other body lumen.

BACKGROUND OF THE INVENTION

Medical technologies are now expanding so that curative therapies maynow be applied directly to the wall of a vascular structure or otherbody lumen (e.g., tubular structure or organ) within the human body. Inmost situations it will be necessary to access the inside (or otherportion) of the wall of a vascular structure or other body lumen inorder to provide therapy to a patient. By way of example but notlimitation, it may be necessary to treat an aneurysm formed in the wallof an artery (e.g., a lateral aneurysm such as a saccular aneurysm, afusiform aneurysm such as a typical abdominal aortic aneurysm), or totreat a lesion formed on the wall of a vascular structure (e.g., anartery or vein) or other tubular or hollow structure. As used herein,the term “vascular structure” is intended to encompass any tubular orhollow structure of the vasculature (e.g., an artery, a vein, a bloodchamber, etc.), and the term “body lumen” is intended to encompass anytubular or hollow structure, including the gastrointestinal orgenitourinary tracts, the lymph system, an air passageway, the interiorof a hollow organ, a passageway through a body structure, etc. As usedherein, the term “wall” of a vascular structure or other body lumen isintended to encompass the inside surface of the wall and/or any otherportion of the wall, including aneurysms, lesions, etc. which may beformed in or on the wall.

Additionally, in many situations it may be desirable to isolate asegment of the vascular structure (or other body lumen) from theremainder of the vascular structure (or other body lumen). By way ofexample but not limitation, a particular therapy applied to the insideof the wall of a vascular structure may create debris which should belocalized and prevented from flowing downstream from the site of thetherapy.

Furthermore, in many situations it may become necessary to apply therapyto the inside of the wall of a vascular structure (or other body lumen)without interrupting the flow of blood (or other fluids) through thevascular structure (or other body lumen).

Thus, there is a substantial need for a novel method and apparatus foraccessing the wall of a vascular structure or other body lumen whilesimultaneously providing “zone isolation” and simultaneously providingfluid bypass capability. Ideally, pressure and fluid (presence orabsence) should be controllable within the isolation zone, therebyfacilitating the use of medical instruments (including cuttinginstruments, biopsy instruments, closure instruments, endoscopicvisualization, etc.), vacuum, electrical energy (e.g., electrosurgery),adhesives and/or other therapies which may be difficult to apply in azone where blood or any other biologic fluid or substance is presentand/or flowing.

SUMMARY OF THE INVENTION

The present invention provides a novel method and apparatus foraccessing the wall of a vascular structure or other body lumen whilesimultaneously providing zone isolation and simultaneously providingfluid bypass capability.

In one preferred form of the invention, the novel method and apparatuspermits pressure and fluid (presence or absence) to be controllablewithin the isolation zone, thereby facilitating the use of medicalinstruments (including cutting instruments, biopsy instruments, closureinstruments, material delivery systems, endoscopes, etc.), vacuum,electrical energy (e.g., electrosurgery), adhesives and/or othertherapies (e.g., agents promoting thrombus, gene therapeutic agents,etc.) which may be difficult to apply in a zone where blood or anotherbiologic fluid or substance is present and/or flowing.

More particularly, the present invention comprises the provision and useof an access system comprising an erectable proximal isolation barrier(e.g., a balloon, a superelastic shape memory alloy ring, etc.), anerectable distal isolation barrier (e.g., a balloon, a superelasticshape memory alloy ring, etc.), and a bypass channel extending betweenthe proximal isolation barrier and the distal isolation barrier, suchthat when the access system is erected in a body lumen, the accesssystem can isolate a segment of the body lumen from the remainder of thebody lumen, while still permitting a fluid to flow independently throughthe isolated segment of the body lumen. Additionally, the access systempreferably comprises a working catheter extending through the proximalisolation barrier and providing access (e.g., for instruments, etc.) tothe wall of the isolated segment of the body lumen. Furthermore, theaccess system can be configured so as to be mountable on a guidewire, sothat the access system can be delivered over a guidewire to a desiredposition within a body lumen.

In one preferred form of the present invention, there is providedapparatus for accessing the wall of a body lumen while simultaneouslyproviding zone isolation and fluid bypass capability, the apparatuscomprising:

an erectable proximal isolation barrier capable of making a sealingengagement with the wall of the body lumen;

an erectable distal isolation barrier capable of making a sealingengagement with the wall of the body lumen;

a bypass channel secured to, and extending between, the proximalisolation barrier and the distal isolation barrier, the bypass channelcomprising a lumen communicating with the region proximal to theproximal isolation barrier and with the region distal to the distalisolation barrier; and

a working catheter passing through the proximal isolation barrier andterminating short of the distal isolation barrier, the working catheterproviding a central lumen for providing access to the wall of the bodylumen between the proximal isolation barrier and the distal isolationbarrier.

In another preferred form of the present invention, there is provided amethod for accessing the wall of a body lumen while simultaneouslyproviding zone isolation and fluid bypass capability, the methodcomprising:

providing an access system comprising:

-   -   an erectable proximal isolation barrier capable of making a        sealing engagement with the wall of the body lumen;    -   an erectable distal isolation barrier capable of making a        sealing engagement with the wall of the body lumen;    -   a bypass channel secured to, and extending between, the proximal        isolation barrier and the distal isolation barrier, the bypass        channel comprising a lumen communicating with the region        proximal to the proximal isolation barrier and with the region        distal to the distal isolation barrier; and    -   a working catheter passing through the proximal isolation        barrier and terminating short of the distal isolation barrier,        the working catheter providing a central lumen for providing        access to the wall of the body lumen between the proximal        isolation barrier and the distal isolation barrier;

deploying the access system within the body lumen;

erecting the distal isolation barrier and the proximal isolationbarrier; and

accessing the wall of the body lumen through the working catheter.

As noted above, the present invention provides a novel method andapparatus for accessing the wall of a vascular structure or other bodylumen while simultaneously providing zone isolation and fluid bypasscapability. In the following description, the present invention maysometimes hereinafter be discussed in the context of application to avascular structure, however, it should be appreciated that this is donesolely for the sake of clarity of illustration and should not beconsidered as limiting the scope of the present invention. Thus, thepresent invention may also be used in conjunction with body lumens otherthan vascular structures, e.g., the gastrointestinal or genitourinarytract, the lymph system, an air passageway, the interior of a holloworgan, a passageway through a body structure, etc.

In another preferred form of the present invention, there is provided amethod for repairing an abnormality in the wall of a body lumen, themethod comprising:

isolating the abnormality in the wall of the body lumen from flow in thebody lumen;

positioning flowable forming material adjacent to the abnormality in thewall of the body lumen; and

transforming the flowable forming material into a substantiallystationary state so as to repair the abnormality in the wall of the bodylumen.

In another preferred form of the present invention, there is providedapparatus for repairing an abnormality in the wall of a body lumen, theapparatus comprising:

a supply of flowable forming material;

zone isolation apparatus for isolating the abnormality in the wall ofthe body lumen from flow in the body lumen; and

positioning apparatus for positioning the flowable forming materialadjacent to the abnormality in the wall of the body lumen so as torepair the abnormality in the wall of the body lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts and further wherein:

FIG. 1 is a schematic perspective view showing the access system of thepresent invention deployed within a vascular structure;

FIG. 2 is a schematic side view showing the access system of FIG. 1deployed within a vascular structure, wherein the vascular structureincludes an aneurysm;

FIG. 3 is a schematic end view, as seen from the distal end, showing theaccess system of FIG. 1 deployed within the vascular structure shown inFIG. 2;

FIG. 4 is a schematic perspective view showing an alternative form of anaccess system deployed within a vascular structure;

FIG. 5 is a schematic side view showing the access system of FIG. 4deployed within a vascular structure, wherein the vascular structureincludes an aneurysm;

FIG. 6 is a schematic perspective view showing an alternative form of anaccess system;

FIG. 7 is a schematic end view of the access system shown in FIG. 6;

FIG. 8 is a schematic sectional view taken along line A-A of FIG. 7;

FIG. 9 is a schematic enlarged view of the segment labeled B in FIG. 8;

FIG. 10 is a schematic perspective view showing an alternative form ofan access system;

FIG. 11 is a schematic end view of the access system shown in FIG. 10;

FIG. 12 is a schematic sectional view taken along line C-C of FIG. 11;

FIGS. 13, 14, 14A and 15-20 illustrate a delivery catheter which mayused to deploy the access system of the present invention at a proceduresite within a vascular structure;

FIGS. 21-26 are schematic views showing one approach for repairing alateral aneurysm using an endoluminal approach and a flowable formingmaterial;

FIGS. 27-32 are schematic views showing another approach for repairing alateral aneurysm using an endoluminal approach and a flowable formingmaterial;

FIGS. 33-38 are schematic views showing still another approach forrepairing a lateral aneurysm using an endoluminal approach and aflowable forming material;

FIGS. 39-44 are schematic views showing an approach for repairing afusiform aneurysm using an endoluminal approach and a flowable formingmaterial;

FIGS. 45-50 are schematic views showing another approach for repairing afusiform aneurysm using an endoluminal approach and a flowable formingmaterial;

FIGS. 51-56 are schematic views showing still another approach forrepairing a fusiform aneurysm using an endoluminal approach and aflowable forming material;

FIGS. 57-63 are schematic views showing another approach for repairing alateral aneurysm using an endoluminal approach and a flowable formingmaterial;

FIG. 64 is a schematic view showing an approach for repairing anabnormality in a body lumen using an endoluminal approach and a flowableforming material; and

FIGS. 65-68 are schematic views showing various constructions for a moldstructure which may be used in conjunction with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Method and Apparatusfor Accessing the Wall of a Vascular Structure or Other Body Lumen whileSimultaneously Providing Zone Isolation and Fluid Bypass Capability

Looking first at FIGS. 1-3, there is shown an access system 5 formed inaccordance with the present invention. Access system 5 generallycomprises an erectable proximal isolation barrier 10 and an erectabledistal isolation barrier 15 for disposition within the lumen of avascular structure or other body lumen. Erectable proximal isolationbarrier 10 and erectable distal isolation barrier 15 are formed so thatthey can (i) initially assume a diametrically-reduced configuration soas to facilitate insertion of access system 5 to a site where aprocedure (e.g., therapy, diagnosis, exploration, etc.) is to beconducted, and (ii) thereafter assume a diametrically-expandedconfiguration once at the procedure site so as to form a fluid-tight(occlusive) seal against the wall of the vascular structure, whereby toisolate a segment of the vascular structure from the remainder of thevascular structure, e.g., while a procedure is performed. In onepreferred form of the invention, proximal isolation barrier 10 anddistal isolation barrier 15 have a peripheral surface texture to helpensure that the barriers will maintain their position in the vascularstructure once deployed. By way of example but not limitation, suchperipheral surface texturing may comprise dimpling, circumferentialribbing, etc. In this respect it will be appreciated that the proximaland distal isolation barriers should remain in place when systolicpressure is present on the outer surfaces of each of the isolationbarriers and atmospheric pressure is present within the isolated segmentof the vascular structure. Furthermore, erectable proximal isolationbarrier 10 and erectable distal isolation barrier 15 are formed so thatthey may be collapsed when desired so as to facilitate removal of accesssystem 5 from the vascular structure, e.g., at the conclusion of theprocedure. By way of example but not limitation, erectable proximalisolation barrier 10 and erectable distal isolation barrier 15 may beformed by inflatable/deflatable balloons, compressible/expandablesuperelastic shape memory alloy (e.g., Nitinol) rings, etc. As a resultof this construction, when access system 5 has been deployed at adesired point in a vascular structure or other body lumen, and erectableproximal isolation barrier 10 and erectable distal isolation barrier 15have been expanded to their sealing condition, access system 5 canisolate a segment of the vascular structure (i.e., the portion locatedbetween erected proximal isolation barrier 10 and erected distalisolation barrier 15) from the remainder of the vascular structure,e.g., while a procedure is performed. This can be important in a varietyof situations, e.g., where the procedure may dislodge debris which couldharm downstream tissue.

Access system 5 is preferably constructed so that erectable proximalisolation barrier 10 and erectable distal isolation barrier 15 may bediametrically-expanded and diametrically-reduced independently of oneanother. In other words, access system 5 is preferably constructed sothat proximal isolation barrier 10 may be diametrically-expanded ordiametrically-reduced regardless of the condition of distal isolationbarrier 15, and vice-versa.

Where erectable proximal isolation barrier 10 and erectable distalisolation barrier 15 are formed out of an inflatable/deflatable balloon,access system 5 also comprises channels for delivering fluid (a liquidor a gas) for inflating/deflating the balloons. By way of example butnot limitation, a channel 16 may be provided for inflating the balloonof erectable proximal isolation barrier 10 and a channel 17 may beprovided for inflating the balloon of erectable distal isolation barrier15.

Access system 5 further comprises a bypass channel 20 secured to, andextending between and through, proximal isolation barrier 10 and distalisolation barrier 15. Bypass channel 20 comprises a central lumen 25(FIG. 3) which opens proximal to proximal isolation barrier 10 anddistal to distal isolation barrier 15, whereby to permit flow from oneside of access system 5 to the other side of access system 5. As aresult of this construction, when access system 5 is deployed in avascular structure so as to isolate a segment of the vascular structurefrom the remainder of the vascular structure, access system 5 can stillpermit blood to flow uninterrupted through the bypass channel 20 whichtraverses the isolated segment of the vascular structure. This can beimportant in a variety of situations, e.g., such as where continuedblood flow is important for the oxygenation of downstream tissues.

In one embodiment, the upstream isolation barrier may be configured soas to channel blood flow into bypass channel 20. Thus, for example, inFIG. 1, proximal isolation barrier 10 may be configured so as to channelblood flow into bypass channel 20. By way of example but not limitation,the upstream side of proximal isolation barrier 10 may be formed with aconcave (e.g., funnel-shaped) surface surrounding the entrance to bypasschannel 20.

Thus it will be seen that access system 5 provides both zone isolation(via proximal isolation barrier 10 and distal isolation barrier 15) anddistal perfusion (via bypass channel 20). These features can beimportant in a variety of situations where zone isolation and distalperfusion are both desirable and/or necessary, e.g., where vasculartrauma needs to be temporarily stabilized while the patient istransported to another site for further treatment, where an aneurysm(e.g., abdominal or thoracic, iliac or femoral, etc.) is bleeding and/orthreatening to rupture, or actually has ruptured, etc. Furthermore, itshould be appreciated that access system 5 may be used on both thearterial and venous sides of the circulation system.

Access system 5 further comprises a working catheter 30 which passesthrough proximal isolation barrier 10 and provides access (e.g., formedical instruments including but not limited to cutting instruments,biopsy instruments, closure instruments, material delivery systems,endoscopes, etc., including for the delivery of adhesives and/or agentsfor promoting thrombus, gene therapeutic agents, etc.) to the wall ofthe isolated length of the vascular structure. Preferably, workingcatheter 30 can slide forward and backward through proximal isolationbarrier 10 such that working catheter 30 can be positioned anywherebetween proximal isolation barrier 10 and distal isolation barrier 15.Additionally, access system 5 is preferably configured so that workingcatheter 30 can be rotated in order that the distal tip 33 of workingcatheter 30 can access substantially the entire circumference of theisolated vessel.

Access system 5 is preferably configured so as to be mountable on aguidewire 35, so that access system 5 may be delivered to a desiredposition within the vascular structure. By way of example but notlimitation, access system 5 may comprise a guidewire channel 40 mountedto proximal isolation barrier 10 and/or working catheter 30 (e.g.,proximal to proximal isolation barrier 10, as shown in FIG. 1), suchthat guidewire 35 may be received within bypass channel 20 and guidewirechannel 40, whereby to permit controlled delivery of access system 5 toa desired location within a vascular structure.

In one preferred form of use, and looking now at FIGS. 1-3, accesssystem 5 may be used to isolate, bypass and access the wall of avascular structure. By way of example but not limitation, access system5 may be used to isolate, bypass and access a lateral aneurysm 45 formedin the wall of a vascular structure 50. In this case, guidewire 35 isfirst deployed down vascular structure 50. Then access system 5, withproximal isolation barrier 10 and distal isolation barrier 15 set intheir diametrically-reduced condition, is advanced over the guidewire toa point adjacent to lateral aneurysm 45. Next, proximal isolationbarrier 10 and distal isolation barrier 15 are set in theirdiametrically-expanded condition, so as to conform to, and seal against,the wall of the vascular structure and thereby create an isolation zone55 which encompasses lateral aneurysm 45. However, it will beappreciated that blood is still able to flow past the isolation zone(e.g., from flow zone 60 to flow zone 65) via bypass channel 20. To theextent that the proximal end of working catheter 30 is open to theatmosphere, blood in the isolation zone may flow out of the isolationzone via the working catheter and be replaced with air. Alternatively,the working catheter may be used to introduce another fluid (e.g.,saline) into the isolation zone. At this point, instruments may beadvanced through working catheter 30 so as to access, and providetherapy to, lateral aneurysm 45. Such instruments may include, but arenot limited to, cutting instruments, biopsy instruments, closureinstruments, material delivery systems, endoscopes, etc. At theconclusion of the procedure, proximal isolation barrier 10 and distalisolation barrier 15 are set in their diametrically-reduced condition,and then access system 5 is withdrawn along guidewire 35. Finally,guidewire 35 is removed from vascular structure 50.

Any debris created in isolation zone 55 during the procedure may beremoved by withdrawing blood/debris from isolation zone 55. In one formof the invention, blood/debris evacuation may be effected by applyingsuction via working catheter 30 while both proximal isolation barrier 10and distal isolation barrier 15 remain erected. In another form of theinvention, blood/debris evacuation may be effected by first returningproximal isolation barrier 10 to its diametrically-reduced configurationwhile retaining distal isolation barrier 15 in itsdiametrically-expanded configuration, then removing blood/debris viasuction, and then returning distal isolation barrier 15 to itsdiametrically-reduced configuration so that access system 5 may beremoved from the vascular structure. This latter approach may beparticularly applicable to angioplasty in the coronary and/or carotidarteries.

FIGS. 4 and 5 show an alternative form of access system 5. The accesssystem shown in FIGS. 4 and 5 is substantially the same as the accesssystem shown in FIGS. 1-3, except that guidewire channel 40 extendsparallel to, but spaced from, bypass channel 20 and bypass channel 20 ispositioned diametrically outboard so as to sit proximate to the wall ofthe vascular structure.

If desired, working catheter 30 may be made detachable from theremainder of access system 5. This feature can be advantageous wherelonger term isolation of a vascular region is desired, e.g., foraneurysm embolization, since it allows the relatively large-bore workingcatheter to be removed, leaving only the zone isolation apparatus andfluid bypass apparatus present in the body lumen.

As noted above, proximal isolation barrier 10 and distal isolationbarrier 15 are designed so as to be able to assume adiametrically-expanded configuration or a diametrically-reducedconfiguration. As also noted above, proximal isolation barrier 10 anddistal isolation barrier 15 may comprise an inflatable/deflatableballoon or a compressible/expandable ring, etc. In this respect itshould be appreciated that where proximal isolation barrier 10 anddistal isolation barrier 15 comprise an inflatable/deflatable balloon,the balloon may extend across substantially the entire diameter of thevascular structure. Alternatively, the balloon may extend only about theperiphery of the diameter of the vascular structure, and a membrane 67may extend across the interior of the balloon, such as is shown in FIG.3. A similar construction may be used where proximal isolation barrier10 and distal isolation barrier 15 comprise a compressible/expandablering, e.g., such as one formed from a superelastic shape memory alloy.Again, a membrane may extend across the interior of the ring.

FIGS. 6-9 show an alternative form of access system 5. The access systemshown in FIGS. 6-9 is substantially the same as the access system shownin FIGS. 1-3 except that proximal isolation barrier 10 and distalisolation barrier 15 comprise multi-segmented balloons 70, and workingcatheter 30 includes an opening 75 connected to the lumen of workingcatheter 30. The use of these multi-segmented balloons 70 to formproximal isolation barrier 10 and distal isolation barrier 15 provide awider, more stable barrier without restricting blood flow through bypasschannel 20. As seen in FIG. 9, channels 80 may be provided betweenadjacent balloons so that the interior of the balloons are incommunication with one another.

FIGS. 10-12 show an alternative form of access system 5. The accesssystem shown in FIGS. 10-12 is substantially the same as the accesssystem shown in FIGS. 6-9 except that channels 80 may be replaced withholes 85 so that the interior of the balloons are in communication withone another.

Deployment

Access system 5 may be deployed in a vascular structure or other bodylumen using a delivery catheter. More particularly, and looking next atFIGS. 13, 14, 14A and 15-20, a delivery catheter 100 comprising adelivery sheath 103 may be provided for advancing access system 5 to aprocedure site within a vascular structure (or other body lumen), andfor erecting access system 5 in the manner previously discussed.Furthermore, delivery catheter 100 may be used for advancing instrumentsdown to the procedure site and/or removing debris from the proceduresite (e.g., a fusiform aortic aneurysm 104 of the type shown in FIG.14A), again in the manner previously discussed. Finally, deliverycatheter 100 may be used to collapse access system 5 and remove it fromthe vascular structure (or other body lumen). In the case where accesssystem 5 comprises inflatable/deflatable balloons in its proximalisolation barrier and/or distal isolation barrier 15, delivery catheter100 may contain one or more fluid supply tubes 105 forinflating/deflating the balloons. It should be appreciated that deliverysheath 103 of delivery catheter 100 may also perform the function of anintroducer sheath, in the sense that it can be secured to the exteriortissue of the patient once the delivery catheter is properly positioned.A hemostatic valve 110, with a side port 115, is preferably located onthe proximal end of the delivery catheter to prevent the loss of bloodthrough the catheter while still allowing the insertion of access system5.

Anatomical Applications

It should be appreciated that access system 5 can be used to provide awide range of therapies to vascular structures, e.g., aneurysm therapy,lesion therapy, infusion therapy, gene therapy, photodynamic therapy,etc. Access system 5 may also be used to repair tears, flaps and leaksin a vascular structure.

Furthermore, it should be also be appreciated that the present inventioncan be used to access structures other than vascular structures, e.g.,the esophagus, stomach, small or large bowel, ureter, bladder, urethra,bronchus, bile duct, ear, nose, fallopian tube, other tubular or hollowstructures within the human body, etc. In essence, the present inventioncan be advantageously used in substantially any body lumen whereisolation, access and/or fluid bypass are desired. Additionally, itshould be appreciated that the zone which is isolated between theproximal and distal isolation barriers could be of varying lengths, andof various diameters as well. Furthermore, many different cathetershapes and sizes may be utilized.

Without limiting the breadth and scope of the present invention, it isanticipated that the present invention is particularly well suited fortreating fusiform aneurysms in the aorta and the larger peripheral bloodvessels.

Furthermore, without limiting the breadth and scope of the presentinvention, it is anticipated that the present invention is particularlywell suited for treating vascular trauma in a variety of situationswhere zone isolation and distal perfusion are both desirable and/ornecessary, e.g., where vascular trauma needs to be temporarilystabilized while the patient is transported to another site for furthertreatment.

Method and Apparatus for Repairing Vascular Abnormalities and/or OtherBody Lumen Abnormalities Using an Endoluminal Approach and a FlowableForming Material

In the foregoing description, there is disclosed a novel method andapparatus for endoluminally accessing the wall of a vascular structureor other body lumen while simultaneously providing zone isolation andfluid bypass capability.

Significantly, this novel method and apparatus for endoluminallyaccessing the wall of a vascular structure or other body lumen can beused in conjunction with another novel method and apparatus in order toendoluminally repair vascular abnormalities and/or other body lumenabnormalities. More particularly, in another aspect of the presentinvention, there is provided a novel method and apparatus for repairingvascular abnormalities and/or other body lumen abnormalities using anendoluminal approach and a flowable forming material.

Looking next at FIGS. 21-26, vascular structure 50 is shown havinglateral aneurysm 45. As is well known, such a lateral aneurysm canpresent a substantial risk to the patient, since the aneurysm mayenlarge and rupture if it is left untreated. To this end, it isgenerally desirable to block the flow of blood into the aneurysm so asto prevent the aneurysm from enlarging and rupturing. In somecircumstances this may be accomplished by placing a clip across the neckof the aneurysm (i.e., via an invasive surgical approach), or byperforming a repair with a graft (in the case of an abdominal aorticaneurysm). However, in other circumstances, it may be difficult to reachthe aneurysm in order to apply the clip, e.g., where the aneurysm islocated deep within the brain or in the case of trauma where nofacilities are available in the field to perform a repair. In thesesituations, and others, it could be desirable to close off the aneurysmusing an endoluminal approach. In this respect it should be appreciatedthat such an endoluminal approach can substantially reduce morbidity,since it eliminates the need to open the skull and avoids trauma tointervening tissue.

To this end, the present invention provides a novel method and apparatusfor closing off an aneurysm using an endoluminal approach. Moreparticularly, the present invention provides a method and apparatus foraccessing an aneurysm via an endoluminal approach and then filling theaneurysm with a flowable forming material so as to close off theaneurysm from blood flow. Significantly, the present invention may alsobe used to endoluminally repair other vascular abnormalities and/or torepair other body lumen abnormalities such as vascular tears, flaps, andperforations using an endoluminal approach and a flowable formingmaterial.

And significantly, the present invention may be facilitated using theaforementioned access system 5.

In accordance with one preferred form of the present invention, ananeurysm in a vascular structure may be repaired in the followingmanner. First, and still looking now at FIGS. 21-26, the aforementionedaccess system 5 is introduced into the vascular structure 50 andadvanced along that vascular structure until erectable proximalisolation barrier 10 and erectable distal isolation barrier 15 straddlethe neck of the aneurysm 45. Then proximal isolation barrier 10 anddistal isolation barrier 15 are erected so as to isolate the segment ofthe vascular structure which is disposed between proximal isolationbarrier 10 and distal isolation barrier 15 (i.e., isolation zone 55)from the remainder of the vascular structure. However, as this occurs,and as discussed previously, bypass channel 20 maintains fluid flow fromone side of the isolation zone to the other side of the isolation zone.This is significant, since it permits uninterrupted oxygenation ofdownstream tissue, and hence permits procedure time to be increasedwithout risk of oxygen deprivation to downstream tissue. The bloodcontained within isolation zone 55 (and aneurysm 45) may then be removedvia opening 75 of working catheter 30 and replaced by another fluid,e.g., air, saline, etc. See FIG. 21. Next, a supply catheter 205 isadvanced down working catheter 30 so that the distal end 210 of supplycatheter 205 emerges from opening 75 and is disposed adjacent to, orwithin, aneurysm 45. See FIG. 22. Then a flowable forming material 215is flowed out of distal end 210 of supply catheter 205 and into aneurysm45. The flow of flowable forming material is continued until aneurysm 45is, preferably, substantially completely filled with flowable formingmaterial 215. See FIGS. 23-25. This flowable forming material 215occupies the interior space of aneurysm 45 and prevents blood fromflowing back into the aneurysm. Thereafter, after flowable formingmaterial 215 has assumed its substantially stationary state, accesssystem 5 is removed from vascular structure 50, allowing blood to returnto the neck of aneurysm 45. However, since the aneurysm has been filledwith flowable forming material 215, blood is unable to re-enter theaneurysm. Thus, the risk of subsequent aneurysm enlargement and ruptureis significantly reduced.

It should be appreciated that inasmuch as access system 5 simultaneouslyprovides both zone isolation capability and fluid bypass capability,access system 5 can be maintained in vascular structure 50 forsubstantial periods of time while flowable forming material 215 isdeployed in position and assumes its substantially stationary state,thereby increasing the possibility of better repair and expanding therange of compositions which may be used for flowable forming material215.

In FIGS. 21-26 discussed above, and FIGS. 27-32, 33-38, 39-44, 45-50,51-56 and 57-63 which are hereinafter discussed, the boundary offlowable forming material 215 is generally shown to have a “wavy”boundary line. These are schematic views which are intended to indicatethat the boundary line of flowable forming material 215 may or may nothave a uniform, highly regular character, depending upon a variety offactors, e.g., the nature of the flowable forming material, the presenceor absence of a mold structure (see below), the face of such a moldstructure, etc. Thus, it should be understood that the use of a “wavy”boundary line in the drawings is not intended to necessarily indicate anon-uniform boundary line for flowable forming material 215. In point offact, where flowable forming material 215 is intended to abut activeblood flow, it is generally desired that flowable forming material 215have a uniform, highly regular character in order to preserve laminarblood flow.

Flowable forming material 215 preferably comprises a bi-state material,having (i) a flowable state prior to disposition within the aneurysm,and (ii) a substantially stationary state after disposition within theaneurysm. In its flowable state, flowable forming material 215 maycomprise a liquid, a foam, a gel, etc. Flowable forming material 215 maycomprise a polymer which is cured in situ, an adhesive which hardens insitu, thrombus, fibrin glue, or any other material consistent with thepresent invention.

By way of example but not limitation, flowable forming material 215 maycomprise a permanent, non-resorbable material. Some candidate permanent,non-resorbable materials are as follows:

(1) a hybrid inorganic/organic-hydraulic cement/polyurethane resin(expands slightly during cure), including:

-   -   (a) a solid, rigid molded matrix;    -   (b) a foaming during cure to produce an open-cell,        microcellular, rigid foam; and    -   (c) a syntactic foam containing pre-formed resorbable gelatin        microspheres containing an active ingredient, such as an        antibiotic;

(2) an organic polymer ambient temperature cure resin, including:

-   -   (a) methyl methacrylate (MMA) liquid monomer catalyzed with        peroxide initiator—this material can cure at body temperature        within several minutes to several hours, depending upon catalyst        type and amount, and has been successfully applied to knee        replacement surgery, etc.—some available options include:        -   (i) a solid, rigid molded poly(methyl methacrylate [PMMA]            matrix;        -   (ii) a syntactic foam containing pre-formed resorbable            gelatin microspheres containing an active ingredient, such            as an antibiotic; and        -   (iii) an Oakes Foamer-produced pre-formed MMA liquid monomer            foam injection to produce rigid, closed cell foam            matrix—this material can expand slightly during cure within            the body; and    -   (b) polyurethane (non-resorbable) liquid pre-polymer blended and        mixed with co-reactant polyol/catalyst component immediately        prior to injection-molding into in-vivo mold cavity—this        material can cure at body temperature within several minutes to        several hours, depending upon catalyst type and amount, and        biocompatible, non-resorbable polyurethane (PUR) monomers and        catalysts are available that produce a soft,        elastomeric-to-hard, rigid, cured PUR matrix—some available        options include:        -   (i) a solid, rigid molded matrix;        -   (ii) a foaming during cure to produce an open-cell,            microcellular, rigid foam—this non-resorbable foam matrix            can be made to contain active components, such as            antibiotics, that leach out at a controlled, adjustable            rate;        -   (iii) a syntactic foam containing pre-formed resorbable            gelatin microspheres that are filled with an active            ingredient, such as an antibiotic

as the gelatin capsule walls are resorbed into the body, the activeingredient becomes leached out in a controlled-release process that canbe adjusted in rate and amount; and

-   -   -   (iv) an Oakes Foamer-produced pre-formed PUR liquid monomer            foam injection to produce rigid, closed cell foam            matrix—this material can expand slightly during cure within            the body.

By way of further example but not limitation, flowable forming material215 may comprise a resorbable material. Some candidate resorbablematerials are as follows:

(1) a resorbable organic polymer ambient temperature cure resin—someavailable options include:

-   -   (a) a bioresorbable polyurethane (contains biodegradable chain        segments) liquid pre-polymer blended and mixed with co-reactant        polyol/catalyst component immediately prior to injection-molding        into in-vivo mold cavity—this material cures at body temperature        within several minutes to several hours, depending upon catalyst        type and amount, and biocompatible, resorbable polyurethane        (PUR) monomers and catalysts are available that produce soft,        elastomeric-to-hard, rigid, cured PUR matrix—resorbable        polyurethane polymer chain segments can be polylactic acid        (PLA), polyglutaric acid (PGA), polyethylene oxide (PEO),        polycaprolactone (PCL), polyvinyl alcohol (PVOH) and        polyethylene/vinyl alcohol (EVOH) segments with tailorable        resorption rates, varying from 15 days to 6 months, depending        upon chain segment type and amount—some options include:        -   (i) a solid, rigid molded matrix;        -   (ii) a foaming during cure to produce an open-cell,            microcellular, rigid foam—this in-vivo resorbable foam            matrix can be made to contain active components, such as            antibiotics, that are released into the body at a            controlled, adjustable rate as the matrix is resorbed;        -   (iii) a syntactic foam containing pre-formed resorbable            gelatin microspheres that are filled with an active            ingredient, such as an antibiotic—as resorbable polymer            matrix and resorbable gelatin capsule walls are resorbed            into the body, the active ingredient becomes leached out in            a controlled-release process that can be adjusted in rate            and amount; and        -   (iv) an Oakes Foamer-produced pre-formed PUR liquid monomer            foam injection to produce rigid, resorbable closed cell foam            matrix—this material can expand slightly during cure within            body; and    -   (b) resorbable hydroxyethylmethacrylate ester (HEMAE) liquid        monomer (this material contains biodegradable ester linkages,        such as PLA, PCL and PGA linkages, attached to methacrylate        monomer unit) catalyzed with peroxide initiator—this material        can cure at body temperature within several minutes to several        hours, depending upon catalyst type and amount—this material can        undergo gradual bioresorption in-vivo—attached ester linkages        can be functional groups, such as an antibiotic, that are        released as ester linkage is hydrolyzed in-vivo—some options        include:        -   (i) a solid, rigid molded poly(HEMAE) matrix;        -   (ii) a syntactic foam containing pre-formed resorbable            gelatin microspheres containing an active ingredient, such            as antibiotic; and        -   (iii) an Oakes Foamer-produced pre-formed MMA liquid monomer            foam injection to produce rigid, closed cell foam            matrix—this material can expand slightly during cure within            body.

In one preferred form of the invention, flowable forming material 215comprises spider silk.

If desired, a mold structure can be erected within isolation zone 55 soas to restrain the flow of flowable forming material 215 while theforming material is still in its flowable state (and before the materialtransforms to its substantially stationary state). To this end, andlooking now at FIGS. 27-31, there is shown a mold structure 220 forrestraining the flow of flowable forming material 215 while the materialtransforms to its substantially stationary state. Mold structure 220 maybe configured to line some or all of isolation zone 55, but in any caseit lines at least the neck of the aneurysm. In FIGS. 27-31, moldstructure 220 is configured to line substantially the entire peripheryof isolation zone 55. In one preferred form of the invention, moldstructure 220 is delivered to isolation zone 55 via access system 5, andis thereafter selectively detachable from the access system so that themold structure can be left in vascular structure 50 upon withdrawal ofaccess system 5. See FIG. 32. In another form of the invention, moldstructure 220 may be permanently secured to access system 5 so that themold structure is withdrawn from vascular structure 50 upon withdrawalof the access system. In either case, mold structure 220 forms a barrierabout the neck of aneurysm 45 so as to prevent flowable forming material215 from extravascating out of the body of aneurysm 45.

In one form of the invention, mold structure 220 preferably comprises asubstantially continuous film such as is shown in FIGS. 27-32. In thisform of the invention, distal end 210 of supply catheter 205 ispreferably formed with a needle-like profile which permits the supplycatheter to puncture through mold structure 220 so as to be able todeliver flowable forming material 215 into the interior of aneurysm 45.Alternatively, mold structure 220 can be formed with an opening thereinwhich permits distal end 210 of supply catheter 205 to deliver flowableforming material into the interior of aneurysm 45. Furthermore, wheremold structure 220 is to be left in place at the conclusion of theprocedure, flowable forming material 215 and mold structure 220 can beconfigured to adhere to one another.

In another form of the invention, and looking now at FIGS. 33-38, moldstructure 220 may comprise a mesh. This mesh has a porosity which issufficiently small vis-à-vis the flow characteristics of flowableforming material 215 that the mesh restrains the flowable formingmaterial within the aneurysm. Again, distal end 210 of supply catheter205 is preferably formed with a needle-like profile which permits thesupply catheter to puncture through mold structure 220 so as to be ableto deliver flowable forming material 215 into the interior of aneurysm45. Alternatively, mold structure 220 can be formed with an openingtherein which permits distal end 210 of supply catheter 205 to deliverflowable forming material into the interior of aneurysm 45. And again,where mold structure 220 is to be left in place at the conclusion of theprocedure, flowable forming material 215 and mold structure 220 can beconfigured to adhere to one another.

FIGS. 21-26, 27-32 and 33-38 all show the present invention being usedin the context of repairing a lateral aneurysm. However, it is alsopossible to use the present invention to treat a fusiform aneurysm. See,for example, FIGS. 39-44, where the aneurysm is filled with flowableforming material 215 without using a mold structure; FIGS. 45-50, wherethe aneurysm is filled with flowable forming material 215 using afilm-type mold structure 220, and FIGS. 51-56 where the aneurysm isfilled with flowable forming material 215 using a mesh-type moldstructure 220. Where the present invention is used to treat a fusiformaneurysm without the provision of a mold structure, it may be necessaryto rotate working catheter 30 about its longitudinal axis so as toenable supply catheter 205 to deliver flowable forming material 215 toall aspects of the aneurysm. Where the present invention is used totreat a fusiform aneurysm with the provision of a mold structure 220, itmay not be necessary to rotate working catheter 30 so as to enablesupply catheter 205 to deliver flowable forming material 215 to allaspects of the aneurysm, although it may still be desirable to providethis option.

If desired, the flowable forming material 215 can be limited to theregion of the aneurysm (e.g., as is shown in FIGS. 21-26, 27-32, 33-38,39-44, 45-50 and 51-56), or it can be allowed to flow into a portion ofthe lumen of vascular structure 50 in order to provide a flange at thebase of the solidified forming material 215. See, for example, FIGS.57-63, which show a flange 225 formed integral with the solidifiedmaterial filling aneurysm 45. In this respect it should be appreciatedthat flange 225 can be formed with or without a mold structure, e.g., apartial circumferential mold structure can be provided to constrainflowable forming material 215 so as to form flange 225 or the flowableforming material can be dispensed in a controlled manner so as to formflange 225. Again, FIGS. 57-63 show this concept in the context of alateral aneurysm; however, is should be appreciated that this sameconcept may be applied to fusiform aneurysms as well.

In the foregoing description, the present invention is discussed in thecontext of repairing an aneurysm in a vascular structure. However, itshould be appreciated that the present invention may also be used torepair other types of vascular abnormalities (e.g., a blood vessel wallwhich is reduced in thickness or strength due to disease, trauma,therapeutic intervention such as an angioplasty, device failure such asleaks and/or migration of an abdominal aortic aneurysm (AAA) graft,etc.) and/or abnormalities in other body lumens (e.g., an intestinalwall which is reduced in thickness or strength due to disease orinjury). Thus, for example, FIG. 64 shows a body lumen 50A which hasflowable forming material 215 lining the wall of body lumen 50A. Alsoshown are a proximal isolation barrier 10, a distal isolation barrier 15and a mold structure 220.

It should be appreciated that mold structure 220 can be provided withvarious configurations other than the simple continuous filmconfiguration shown in FIGS. 27-32 and/or the simple mesh configurationshown in FIGS. 33-38. Thus, for example, mold structure 220 can beformed with longitudinally-extending ribs 230 (FIGS. 65 and 66),circumferentially-extending ribs 230 (FIGS. 67 and 68), and/or otherconfigurations. If desired, where proximal isolation barrier 10 anddistal isolation barrier 15 comprise inflatable balloon structures, thelongitudinally-extending ribs 230 (FIGS. 65 and 66) and/or thecircumferentially-extending ribs 230 (FIGS. 67 and 68) can also compriseballoons, which may or may not be in fluid communication with one ormore of the balloons which form proximal isolation barrier 10 and distalisolation barrier 15.

Modifications

While the present invention has been described in terms of certainexemplary preferred embodiments, it will be readily understood andappreciated by one of ordinary skill in the art that it is not solimited, and that many additions, deletions and modifications may bemade to the preferred embodiments discussed

1. A method for repairing an abnormality in the wall of a body lumen, the method comprising: isolating the abnormality in the wall of the body lumen from flow in the body lumen; positioning flowable forming material adjacent to the abnormality in the wall of the body lumen; and transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen. 2.-8. (canceled)
 9. A method according to claim 1 wherein the abnormality comprises one from the group consisting of a reduced wall thickness, a perforation, a tear and a flap.
 10. A method according to claim 9 wherein the flowable forming material is integrated with the wall of the body lumen so as to repair the abnormality. 11.-37. (canceled)
 38. A method according to claim 1 wherein the flowable forming material comprises a non-resorbable material.
 39. A method according to claim 38 wherein the flowable forming material comprises at least one selected from the group consisting of a hybrid inorganic/organic--hydraulic cement/polyurethane resin and an organic polymer ambient temperature cure resin.
 40. A method according to claim 39 wherein the flowable forming material comprises at least one selected from the group consisting of methyl methacrylate (MMA), polymethyl methacrylate [PMMA] and polyurethane. 41.-43. (canceled)
 44. A method according to claim 1 wherein the flowable forming material comprises polylactic acid (PLA).
 45. A method according to claim 1 wherein the flowable forming material comprises spider silk. 46.-49. (canceled)
 50. A method according to claim 46 wherein the mold structure comprises a mesh.
 51. A method according to claim 50 wherein the mesh is in the form of a cylinder.
 52. (canceled)
 53. A method according to claim 46 wherein the mold structure comprises a partial circumferential configuration.
 54. Apparatus for repairing an abnormality in the wall of a body lumen, the apparatus comprising: a supply of flowable forming material; zone isolation apparatus for isolating the abnormality in the wall of the body lumen from flow in the body lumen; and positioning apparatus for positioning the flowable forming material adjacent to the abnormality in the wall of the body lumen so as to repair the abnormality in the wall of the body lumen.
 55. Apparatus according to claim 54 wherein the flowable forming material comprising a bi-state material having (i) a flowable state, and (ii) a substantially stationary state.
 56. Apparatus according to claim 54 wherein the flowable forming material comprises polylactic acid (PLA).
 57. Apparatus according to claim 54 wherein the flowable forming material comprises spider silk.
 58. Apparatus according to claim 54 wherein the zone isolation apparatus isolates the abnormality in the wall of the body lumen from flow in the body lumen while still allowing flow through the body lumen.
 59. Apparatus according to claim 58 wherein the zone isolation apparatus comprises: an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen; an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen; a bypass channel secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass channel comprising a lumen communicating with the region proximal to the proximal isolation barrier and with the region distal to the distal isolation barrier; and a working catheter passing through the proximal isolation barrier and terminating short of the distal isolation barrier, the working catheter providing a central lumen for providing access to the wall of the body lumen between the proximal isolation barrier and the distal isolation barrier.
 60. Apparatus according to claim 59 wherein the erectable proximal isolation barrier and the erectable distal isolation barrier are constructed so as to be capable of assuming a diametrically-reduced configuration and a diametrically-expanded configuration, and further wherein the erectable proximal isolation barrier and the erectable distal isolation barrier are in their diametrically-expanded configuration when making a sealing engagement with the wall of the body lumen.
 61. Apparatus according to claim 59 wherein at least one of the erectable proximal isolation barrier and the erectable distal isolation barrier comprises an upstream isolation barrier, and further wherein the upstream isolation barrier is configured to channel blood flow into the bypass channel.
 62. Apparatus according to claim 54 further comprising a mold structure configured to constrain the flowable forming material in the space between the wall of the body lumen and the mold structure.
 63. Apparatus according to claim 62 wherein the mold structure is penetrable.
 64. Apparatus according to claim 62 wherein the mold structure comprises a substantially continuous film.
 65. Apparatus according to claim 64 wherein the substantially continuous film is in the form of a cylinder.
 66. Apparatus according to claim 62 wherein the mold structure comprises a mesh.
 67. Apparatus according to claim 66 wherein the mesh is in the form of a cylinder.
 68. Apparatus according to claim 62 wherein the mold structure comprises a circumferential configuration.
 69. Apparatus according to claim 62 wherein the mold structure comprises a partial circumferential configuration. 